NCT06250062已完成2 期
A Phase II, Randomized, Double-blind, Placebo-controlled , Multicenter Study to Evaluate the Preliminary Efficacy and Safety of Subcutaneous Injection of Recombinant Humanized Anti-IL-17A Monoclonal Antibody（JS005） in Adult Patients With Active Ankylosing Spondylitis
Shanghai Junshi Bioscience Co., Ltd.39 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2024年1月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 39
- 主要终点
- Assessment of SpondyloArthritis International Society criteria (ASAS）40
研究概览
简要总结
This is a multicentre, randomized, double-blind, parallel, placebo-controlled Phase II clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of JS005 in the treatment of active ankylosing spondylitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily particpate in this clinical study and sign the informed consent form.
- •Male and female patients aged 18-75 years at the time of screening (both inclusive)
- •Meet the diagnosis of active Ankylosing Spondylitis(AS), have a record of radiological evidence consistent with the Modified New York Classification Criteria for ankylosing spondylitis as revised in 1984
- •Diagnosis of active AS (active AS is defined as: BASDAI >= 4, total back pain score >=4, and BASDAI second question spinal pain score >=4)
排除标准
- •Pregnant or lactating women.
- •Active diseases that may confound the evaluation of JS005: other autoimmune inflammatory diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, vasculitis, etc.) or chronic pain other than ankylosing spondylitis (including but not limited to fibromyalgia, osteoarthritis, etc.).
- •4. Active inflammatory bowel disease within 6 months prior to randomization.
- •Recurrent anterior uveitis or acute anterior uveitis within the last 4 weeks prior to randomization.
- •6. History or evidence of active or latent tuberculosis (TB), defined as a positive interferon gamma release assay (IGRA) or purified protein derivative (PPD) at the time of screening.
- •Positive hepatitis B virus test result
- •Prior exposure to JS005 or any other biologic that directly targets IL-17 or the IL-17 receptor.
- •9. use of >= 2 TNF-α inhibitors.
研究组 & 干预措施
Recombinant humanized IL-17A Monoclonal Antibody（JS005）150mg
Experimental
干预措施: Placebo（JS005） (Drug)
Recombinant humanized IL-17A Monoclonal Antibody（JS005）300mg
Experimental
干预措施: Recombinant humanized IL-17A Monoclonal Antibody（JS005） (Drug)
Placebo（JS005）
Experimental
干预措施: Placebo（JS005） (Drug)
Recombinant humanized IL-17A Monoclonal Antibody（JS005）150mg
Experimental
干预措施: Recombinant humanized IL-17A Monoclonal Antibody（JS005） (Drug)
Recombinant humanized IL-17A Monoclonal Antibody（JS005）300mg
Experimental
干预措施: Placebo（JS005） (Drug)
结局指标
主要结局
Assessment of SpondyloArthritis International Society criteria (ASAS）40
时间窗: 16 weeks
Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）40 response criteria at week 16.
次要结局
- Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 2.0(16 weeks and 32 weeks)
- Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) < 1.3(16 weeks and 32 weeks)
- Assessment of SpondyloArthritis International Society criteria (ASAS) partial remission(16 weeks and 32 weeks)
- Pharmacokinetic(PK)(40 weeks)
- Immunogenicity(40 weeks)
- Assessment of SpondyloArthritis International Society criteria (ASAS）40(32 weeks)
- Assessment of SpondyloArthritis International Society criteria (ASAS）20(16 weeks and 32 weeks)
- Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP)(16 weeks and 32 weeks)
- Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) <2.1(16 weeks and 32 weeks)
- Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 1.1(16 weeks and 32 weeks)
研究者
研究点 (39)
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